替米沙坦左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.92471524741247232469824696247150.08
213.92497025040250050.20
单位质量响应值RSD%判断
1778.061798.920.83数据可信
加速3月-供试品溶液-2024050921批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min126060-26060102.224101.463.24102.22101.463.24
226296-26296103.149103.15
325333-2533399.37299.37
424516-2451696.16796.17
526057-26057102.212102.21
626932-26932105.644105.64
10min126367-26367103.428100.712.75104.45101.722.75
225925-25925101.694102.73
325189-2518998.80799.80
424484-2448496.04197.00
525968-25968101.863102.88
626114-26114102.435103.49
15min126195-26195102.753100.323.64104.81102.343.62
226035-26035102.125104.17
325120-2512098.536100.52
423902-2390293.75995.68
525822-25822101.290103.33
626380-26380103.479105.56
20min125657-25657100.64399.531.68103.73102.551.72
225563-25563100.274103.34
324987-2498798.015100.98
424703-2470396.90199.76
525772-25772101.094104.15
625552-25552100.231103.35
30min126018-26018102.05999.763.75106.15103.783.71
225348-2534899.431103.50
324786-2478697.226101.17
423944-2394493.92397.75
525922-25922101.682105.75
626581-26581104.267108.39
极限125646-25646100.60099.213.19105.71104.233.17
225703-25703100.823105.89
324402-2440295.720100.64
424143-2414394.70499.47
525826-25826101.306106.39
626031-26031102.110107.27
替米沙坦左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.92484024812248632486624922248610.17
213.92462224693246580.21
单位质量响应值RSD%判断
1788.561773.960.58数据可信
长期3月-供试品溶液-2024050921批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min124519-2451996.568100.272.6796.57100.272.67
226523-26523104.460104.46
325823-25823101.703101.70
425507-25507100.459100.46
525254-2525499.46299.46
625134-2513498.99098.99
10min124187-2418795.26098.233.4696.2399.243.45
226180-26180103.109104.15
325330-2533099.762100.78
425517-25517100.498101.50
524426-2442696.20197.20
624011-2401194.56795.56
15min124185-2418595.252100.854.7297.17102.844.68
226316-26316103.645105.72
326052-26052102.605104.62
427371-27371107.800109.81
525272-2527299.533101.49
624445-2444596.27698.21
20min124219-2421995.38699.103.3898.26102.093.37
226226-26226103.291106.40
325811-25811101.656104.70
425631-25631100.947104.03
524826-2482697.777100.73
624255-2425595.52898.43
30min124334-2433495.83998.172.8799.66102.162.88
225745-25745101.396105.54
325698-25698101.211105.27
425132-2513298.982103.08
524615-2461596.946100.88
624037-2403794.66998.52
极限124163-2416395.16597.913.4299.95102.883.38
226420-26420104.055109.21
325233-2523399.380104.45
424528-2452896.603101.69
524543-2454396.662101.56
624276-2427695.610100.41
替米沙坦左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.92482624712246732471924700247260.24
213.92499024959249740.09
单位质量响应值RSD%判断
1778.851796.690.71数据可信
中间条件3月-供试品溶液-2024050921批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min122558-2255888.52195.273.8988.5295.273.89
223863-2386393.64293.64
324531-2453196.26496.26
424823-2482397.41097.41
525119-2511998.57198.57
624776-2477697.22597.23
10min123235-2323591.17897.613.7192.0698.563.71
224750-2475097.12398.06
324623-2462396.62597.59
425848-25848101.432102.41
525447-2544799.858100.84
625336-2533699.423100.39
15min123206-2320691.06496.853.4692.8698.783.47
224443-2444395.91897.83
324397-2439795.73897.67
425427-2542799.780101.77
525301-2530199.285101.27
625306-2530699.305101.27
20min123347-2334791.61797.683.3194.33100.583.29
225049-2504998.296101.16
325523-25523100.156103.04
424796-2479697.304100.29
525631-25631100.580103.56
625001-2500198.108101.07
30min123214-2321491.09697.504.0094.72101.373.96
224982-2498298.034101.88
324455-2445595.96599.85
426241-26241102.974106.93
525191-2519198.854102.84
624987-2498798.053101.99
极限123207-2320791.06895.653.2195.60100.503.20
224285-2428595.298100.13
324241-2424195.12699.97
424996-2499698.088103.08
525462-2546299.917104.89
624063-2406394.42799.35
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